Packaging pouches for medical devices typically comprises a transparent thermoplastic sheet, such as polycoated polyester, polycoated nylon, polyethylene or polypropylene film, thermally sealed along the periphery to a gas permeable microbial barrier layer, such as medical grade paper or spunbound polyolefin, hereinafter referenced as a breather pouch.
One of the more popular materials for use as the gas permeable microbial barrier layer is a spunbonded polyolefin material known as TYVEK® (a registered trademark of E.I. du Pont de Nemours and Company). TYVEK® spunbonded polyolefin has been in use for a number of years as a material for sterile packaging applications because of its light weight, excellent strength, good microbial barrier properties, and reasonable permeability to sterilization gases such a ethylene oxide and hydrogen peroxide.
Breather pouches allow medical devices retained within the pouch to be sterilized after the device has been sealed within the pouch by a process known as medical sterilization packaging. Briefly, medical sterilization packaging is a packaging method which involves placement of the medical device within a breather pouch, thermally sealing the breather pouch, and exposing the pouch to a sterilizing gas, such as ethylene oxide or hydrogen peroxide. The sterilizing gas will penetrate through the gas permeable layer of the breather pouch and sterilize the medical device within the pouch without disturbing the sealed condition of the pouch.
Breather pouches are generally provided as stacks of single pouches having one open end to manufacturers of medical devices. The medical devices are placed within each pouch by hand and the open end of the pouch thermally sealed by hand. Such hand packaging of medical devices is slow, labor intensive and expensive. Hence, a need exists for an automated method of packaging medical devices into breather pouches.